This medicine is authorised for use in the European Union.


An overview of Torisel and why it is authorised in the EU

Torisel is a medicine used to treat patients with the following types of cancer:

  • advanced renal cell carcinoma (a kidney cancer). ‘Advanced’ means that the cancer has started to spread;
  • mantle cell lymphoma (a cancer of B cells, a type of white blood cell). Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.

These diseases are rare, and Torisel was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates.

Torisel contains the active substance temsirolimus.

This EPAR was last updated on 15/08/2018

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Lymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Boulevard de la Plaine 17
1050 Bruxelles

Product information

07/08/2018 Torisel - EMEA/H/C/000799 - T/0071


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Renal-cell carcinoma

Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.

Mantle-cell lymphoma

Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Assessment history

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